FDA 510(k)

Simplexa VZV Swab Direct, Simplexa VZV Positive Control Pack

K-번호: K192376 · 2019-11-26

결정일2019-11-26

제품 코드PGI

자문 위원회미 (Original text: MI)

결정Substantially Equivalent

기기 요약

Simplexa VZV Swab Direct, Simplexa VZV Positive Control Pack is the device name listed in this FDA 510(k) record. The listed applicant is Diasorin Molecular, LLC. It received FDA 510(k) clearance on 2019-11-26 under 510(k) number K192376. The device is classified under product code PGI. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Simplexa VZV Swab Direct, Simplexa VZV Positive Control Pack?

Simplexa VZV Swab Direct, Simplexa VZV Positive Control Pack is a medical device that received FDA 510(k) clearance on 2019-11-26. The listed applicant is Diasorin Molecular, LLC. The 510(k) number is K192376.

When did Simplexa VZV Swab Direct, Simplexa VZV Positive Control Pack receive FDA 510(k) clearance?

Simplexa VZV Swab Direct, Simplexa VZV Positive Control Pack received FDA 510(k) clearance on 2019-11-26, under 510(k) number K192376.

Who is the listed applicant for Simplexa VZV Swab Direct, Simplexa VZV Positive Control Pack?

The FDA 510(k) record lists Diasorin Molecular, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Simplexa VZV Swab Direct, Simplexa VZV Positive Control Pack?

The FDA product code for Simplexa VZV Swab Direct, Simplexa VZV Positive Control Pack is PGI.

Diasorin Molecular, LLC를 신청인으로 등재한 기타 기록

K260333연결 NES 그룹 A 스프레드; 연결 NES 그룹 A 스프레드 컨트롤 스웨브 키트 K251978연결 NES 인플루엔자 A/B, RSV 및 COVID-19 K252387Simplexa™ COVID-19/ Flu A/B & RSV Direct (MOL4450); Simplexa™ COVID-19/ Flu A/B & RSV Positive Control Pack (MOL4460)K220963Simplexa COVID-19 & Flu A/B Direct K202755Simplexa Congenital CMV Direct and Simplexa Congenital CMV Positive Control Pack K212147Simplexa COVID-19 Direct

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